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Immune Therapy Reported to Reduce MRI-Detected MS Disease Activity in Relapsing MS in Two Small Studies

February 28, 2018

SUMMARY

Treatment with ATX-MS-1467 (Apitope) – an injected immune therapy whose early development was supported by the National MS Society through Fast Forward, the Society’s commercial research funding program – was reported to reduce disease activity on MRI scans in two small open-label studies involving people with relapsing MS. These studies were conducted to help determine the optimal protocol for administering this experimental treatment.

Apitope plans to launch a second Phase II trial for the treatment of MS, which is expected to begin later in 2018.

DETAILSBackground: Multiple sclerosis involves immune attacks launched on the brain and spinal cord. Nerve-insulating myelin is a key target. Apitope has developed an approach to identify pieces of human proteins, called “peptides,” that might be able to reinstate “immune tolerance” – in effect, train immune cells to ignore myelin – to suppress MS attacks. ATX-MS-1467 is a mixture of four such peptides that can be injected into or under the skin. An earlier clinical trial in 6 people with secondary-progressive MS indicated that the drug was well tolerated with early evidence of potential efficacy. The two current studies were conducted to help determine the optimal protocol for administering this treatment.

Apitope was the first in a series of partnerships driven by the National MS Society through Fast Forward, with early stage biotechnology companies.

The studies: Participants had relapsing MS and also had a particular gene (HLA-DRB1*15) which is a common immune-related gene that has been linked to the risk of developing MS. Both studies were “open label,” meaning that all involved were aware of the treatment being given, and there was no control group.

In one study, 43 participants were administered increasing partial doses of ATX-MS-1467 every 14 days over eight weeks, and then a full dose every 14 days for eight weeks. Treatment was injected either under the skin, or into the skin. In participants who received treatment into the skin, disease activity on MRI scans reduced significantly from the beginning of treatment to week 16. These participants were followed for an additional 32 weeks after their last treatment. By the end of this period, disease activity on MRI scans had returned to the original levels. Adverse events were mild or moderate, and mostly included injection site reactions.

In the second study, 19 participants received increasing partial doses every 14 days for four weeks and then a full dose every 14 days for 16 weeks. All received treatment via injection into the skin. Disease activity on MRI scans reduced significantly, and the reductions were maintained during a 16-week follow-up period after the last treatment. Adverse events were mild or moderate, including mostly injection site reactions, two cases of hair loss, and one case of diarrhea (which resulted in discontinuation of treatment).

Next Steps: The results of these study and further phase II and phase III studies will help to determine whether ATX-MS-1467 has potential to be developed into a safe and effective treatment for people with MS. According to its website, Apitope plans to launch a second Phase II trial for the treatment of MS, which is expected to begin later in 2018.

These results are an example of how the Society through Fast Forward is ensuring that promising MS treatments don’t languish between the lab and clinical testing, by providing critical advice, driving connections and directing vital funding to biotech companies and other small commercial entities.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.